Caldera Medical Announces FDA Clearance for New Desara® TVez for Stress Urinary Incontinence

Caldera Medical, a medical device company that develops best-in-class surgical products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, and Polyps announced the launch of Desara^®TVez, an expansion to their Desara^® Family of products. Caldera Medical, a medical device company that develops best-in-class surgical products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, and Polyps announced the launch of Desara^®TVez, an expansion to their Desara^® Family of products. Read more.

Source: Business Wire, December 2, 2021

Individual Pessaries For More Successful Treatment Of Stress Incontinence Through 3D Printing

Simply Standing up, doing sports, or just laughing, it’s extremely unpleasant whenever urine suddenly leaks uncontrollably. Colloquially referred to as a ‘weak bladder’, it’s known as Stress Urinary Incontinence in medical terms. Although about one in three women suffers from uncontrolled urine leakage, incontinence is still taboo. Initially merely a physical problem, it also quickly weighs on the soul. For fear of unpleasant situations, those affected often withdraw and avoid social activities with families and friends. 3D printed pessaries may relieve the burden. Read more.

Source: The Science Times, November 14, 2021

FDA Authorizes Study Exploring Novel Device for Bladder Incontinence

The FDA has approved the launch of an investigational device exemption trial exploring a novel implantable tibial neuromodulation (TNM) device designed to relieve symptoms of bladder incontinence. The trial, known as the TITAN 1 Feasibility Study, is a multicenter, prospective trial aiming to enroll 20 patients at 8 clinical sites in the United States. The patients will have the device implanted in the posterior tibial nerve near the ankle. They will be followed for 12 months to assess the feasibility of the product. Enrollment for the trial is expected to commence in May. Medtronic currently offers several products for bladder control, including the InterStim sacral neuromodulation systems and the NURO percutaneous tibial neuromodulation (PTNM). Read more.

Source: Urology Times, April 27, 2021

Axonics® Expands into Stress Urinary Incontinence with the Acquisition of Bulkamid®

Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today announced that it has acquired privately-held Contura Ltd. and its flagship product, Bulkamid, a best-in-class urethral bulking agent for women with stress urinary incontinence (SUI). Read more.

Source: Business Wire, February 25, 2021

UH Researcher Receives $1.6 Million to Reverse Urinary Incontinence

A University of Houston researcher is working to reverse pelvic floor dysfunction which can result in urinary incontinence, a condition affecting 30-60% of the female population and 5-15% of males. Stress urinary incontinence (SUI), the most common type of urinary incontinence in women, relates to the unintentional loss of urine which happens during movement or activities like sneezing, coughing or exercising. The condition is associated with pregnancy and aging and affects the pelvic floor, a group of muscles stretching from the pubic bone to the tail bone that contributes to continence. Read more.

Source: News-Medical.Net, October 15, 2020

Axonics® Reports 2-Year Clinical Results from ARTISAN-SNM Pivotal Study

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has reported full 2-year clinical results from its ARTISAN-SNM pivotal study. Read more.

Source: Business Wire, September 10, 2020

Viveve Completes Enrollment in Short-Term Feasibility Study for Stress Urinary Incontinence

Viveve Medical, Inc. (VIVE), a medical technology company focused on women’s intimate health, announced today that it has completed enrollment in its three-arm, three-month feasibility study to compare Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. The Investigational Testing Application (ITA) study, approved by the Canadian Ministry of Health, was initiated in January 2020. Read more.

Source: Yahoo Finance!, March 4, 2020

Atlantic Therapeutics Announces FDA Clearance for Over-the-Counter Use of INNOVO®

Atlantic Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to INNOVO^®, a non-invasive, clinically proven and wearable device that treats the root cause of bladder weakness, known clinically as stress urinary incontinence (SUI). INNOVO^® was previously available in the U.S. by prescription, with more than 3.5 million safe and successful therapy sessions delivered worldwide. Read more.

Source: Yahoo! Finance, February 6, 2020

Contura Nabs FDA Nod for Female Incontinence Device

Contura has earned FDA approval for an injectable hydrogel [Bulkamid] to treat stress urinary incontinence in women, according to a premarket approval order posted by the agency Monday. The permanently implanted device acts as a scaffold for cells to grow through, supporting the closing mechanism of the urethra for better control of urine. Approval of the Bulkamid implant was based on a study of 228 women that showed 75% of those who got the device reported dryness or improvement in their symptoms. Read more.

Source: MedTechDive, February 4, 2020

Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing a novel implantable rechargeable sacral neuromodulation (“SNM”) device for the treatment of urinary and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”). The Axonics System is the first rechargeable SNM system approved for sale in the United States, Europe, Canada and Australia. The FDA approval grants Axonics the right to market its product in the United States for the clinical indication of fecal incontinence. The approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted. Axonics has an additional pre-market approval (“PMA”) filing currently under review with the FDA for the clinical indications of overactive bladder (urinary urgency incontinence and urinary urgency frequency) as well as urinary retention for which the Company anticipates a determination in the near term. Read more.

Source: Business Wire, September 9, 2019